Medical Devices Lead Auditor
hace 3 semanas
Medical Devices Lead Auditor & Training Specialist
We are seeking a Medical Devices Lead Auditor & Training Specialist to join our Global Medical Device team.
This role will have dual responsibilities as Lead Auditor and Auditor Training Specialist. As a Lead Auditor, you will develop and deliver auditor training materials, evaluate and approve trainee audits, and conduct management system audits.
You will also support the qualification of new auditors and be a key expert of contact and mentor to colleagues.
As a Training Specialist/Facilitator, you will help prepare, deliver, and assess training and integration aspects of the qualification process.
Key areas of responsibility include supporting the development of the global SGS medical device auditor network, acting as a key point of contact for SGS medical device offices, and contributing to the continuous improvement of processes and tools used across the SGS network.
You will maintain your own auditor competences, conduct audits at clients' sites and remotely, and work alone or lead audit teams as appropriate.
The ideal candidate will have full knowledge of EUMDR 2017/745, previous auditing experience within an MDR notified body, and a university degree or equivalent qualification in relevant sciences.
Additional qualifications include general expertise including risk management, usability, biocompatibility, clinical standards, and guidance documents relevant to medical devices.
The candidate should also meet the prerequisite per LPMDREG7001 for MDR and/or LPIVDREG7106 for IVDR, demonstrate 2 years working knowledge on MDN/MDA/MDS codes for MDR, and have good English written and verbal skills.
As a Training Specialist/Facilitator, the ideal candidate will have proven experience in training and assessment, experience in creating and maintaining training material, excellent communication skills, and IT literacy.
We offer a globally recognized and stable company, a flexible schedule and work model, access to SGS University and Campus, a multinational environment, and comprehensive benefits platform.
Seniority level: Mid-Senior level, Employment type: Full-time, Job function: Accounting/Auditing, Industries: Medical Equipment Manufacturing.
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